ApHER has entered a new cooperation with EasyTrial ApS and IWA Consulting ApS. This cooperation aims to support our customers throughout the several phases of Medical Device production by offering qualified advice and guidance in respect of regulatory compliance. This is especially important due to the new European Medical Device Regulation 2017/745, which will come into force on 26.05.2021.

IWA Consulting ApS are specialists in Regulatory Science and QA, whereas EasyTrial provide Clinical Trial Management Software and Data Storage. Through this collaboration, we can ensure our customers a coherent and supportive process.

The various phases of Medical Device production are shown in the table, where each partner’s areas of competence appear as well.